Clinical trials are a critical process to ensure the safety, efficacy, and quality of new drugs before they are authorized for market use. These trials adhere to strict international standards and are conducted under the supervision of health regulatory agencies. Below, the ACADEMY OF MEDICAL SCIENCES outlines the basic process of a clinical drug trial service.

1. Defining Objectives and Designing the Trial

a. Setting Objectives

Before starting the trial, the research team must establish clear objectives, including:

• Evaluating efficacy: Does the drug achieve the intended therapeutic effect?
• Assessing safety: Does the drug cause any significant side effects?
• Determining optimal dosage: What dosage offers the best effectiveness with the fewest side effects?

b. Trial Design

The trial must adhere to scientific principles:

• Randomized Controlled Trials (RCTs): Participants are randomly assigned to groups.
• Double-blind trials: Both participants and researchers are unaware of the specific group assignments to minimize bias.
• Control groups: Comparing results between the drug group and a placebo or standard treatment group.

c. Approval Process

Once the design is complete, the trial protocol must be submitted to regulatory authorities and ethical review boards for approval. In Vietnam, the Ministry of Health or the Drug Administration of Vietnam typically oversee this process.

2. Phases of a Clinical Trial

The clinical trial process is generally divided into four main phases, each with specific goals and characteristics.

Phase 1: Small-Scale Safety Testing

• Participants: 20–100 healthy volunteers.
• Goals: Assess the drug’s basic safety; Study pharmacokinetics (how the drug moves through the body) and pharmacodynamics (the drug’s effects).
• Duration: A few months.

Phase 2: Efficacy Evaluation

• Participants: 100–500 patients with the target condition.
• Goals: Preliminary evaluation of the drug’s effectiveness; Continued safety assessment.
• Duration: Several months to 2 years.
• Expected outcome: Data from this phase determines whether the drug can proceed to larger-scale trials.

Phase 3: Large-Scale Testing

• Participants: 1,000–5,000 patients, often from multiple countries.
• Goals: Confirm the drug’s effectiveness and safety under real-world conditions; Identify rare side effects.
• Duration: 1–4 years.
• Significance: This phase is crucial for obtaining regulatory approval for the drug.

Phase 4: Post-Market Surveillance

• Participants: Tens of thousands of patients using the drug in real-world settings.
• Goals: Monitor long-term effects; Assess safety on a large scale; Identify new applications of the drug.

3. Data Management and Results Analysis

a. Data Collection

Data from the trials are systematically collected using tools such as:

• Medical records.
• Adverse event reports.
• Clinical Data Management Systems (CDMS).

b. Statistical Analysis

Statistical methods are used to:

• Compare efficacy between trial groups.
• Identify relationships between dosage and side effects.
• Ensure the accuracy and reliability of the data.

c. Reporting Results

The trial results are compiled into detailed reports, including:

• Clinical data analysis.
• Recommended dosage.
• Documented adverse effects.

These reports are submitted to regulatory agencies such as the FDA (U.S.), EMA (Europe), or the Ministry of Health (Vietnam) for drug approval.

4. Risk Management and Ethics in Clinical Trials

a. Protecting Participant Rights

• Informed consent: Participants must be fully informed about the objectives, benefits, and risks before enrollment.
• Data confidentiality: Personal information of participants must be strictly protected.

b. Risk Management

• Regular monitoring: Trials are supervised by independent committees such as Data Safety Monitoring Boards (DSMB).
• Incident response: If severe side effects are detected, the trial may be temporarily halted for reassessment.

5. Drug Registration and Market Authorization

After completing the trials, the drug registration dossier is submitted to regulatory agencies for approval. This process includes:

• Submitting the registration dossier: Includes data from all trial phases, manufacturing process details, and quality control measures.
• File assessment: Regulatory agencies verify the completeness and accuracy of the data.
• Safety-efficacy evaluation: Drugs are approved only if their benefits outweigh their risks.

6. Technology Applications in Clinical Trials

Technology plays an increasingly significant role in clinical trial processes:

• Artificial intelligence (AI): Enables faster and more accurate data analysis.
• Electronic systems: Minimize errors in data collection and management.
• Remote trials: Facilitate participation without requiring patients to visit trial sites.

7. Conclusion

Clinical trials are not only a critical step in the drug development process but also a commitment to safeguarding public health. This process requires close collaboration among researchers, regulatory authorities, and the medical community. The ACADEMY OF MEDICAL SCIENCES remains dedicated to advancing this field, contributing to enhanced quality and safety in drug use worldwide.